Background As biobank research has become increasingly widespread within biomedical research, study-specific consent to each study, a model derived from research involving traditional interventions on human subjects, has for the sake of feasibility gradually given way to alternative consent models which do not require consent for every new study. Besides broad consent these models include tiered, dynamic, and meta-consent. However, critics have pointed out that it is normally not known at the time of enrolment in what ways samples deposited in a biobank may be used in future research and that, for a consent to be informed, exactly this kind of knowledge is required. Therefore, there is an ongoing debate about the ethical acceptability of going for less than study-specific consent. Main text In light of this debate we address the question of how to best protect participants against relevant risks and violations of autonomy. We apply the central aims of the informed consent process to the unique circumstances of biobank research where samples and data in many cases are stored for long periods of time and reused in subsequent studies. Thereby we are able to formulate a set of criteria focusing both on the risk of informational harm and the potential violation of participants’ values. We compare existing models of consent based on their ability to satisfy the criteria, and we find that the broad consent model offers the best level of protection for participants, although, it suffers from a few important deficiencies with regards to protection against participant value violations and long-term protection of autonomy, if it is applied without qualifications. For this reason, we propose modifications to the current broad consent model, in order to ensure that it provides protection of autonomy and participant values through strong ethical review and continuous communication. Conclusion We conclude that a modified form of broad consent is ethically superior in biobank research, not only because it is most feasible but primarily because it offers the best available protection against the hazards facing research subjects in this form of research.
Current debate and policy surrounding the use of genetic editing in humans often relies on a binary distinction between therapy and human enhancement. In this paper, we argue that this dichotomy fails to take into account perhaps the most significant potential uses of CRISPR-Cas9 gene editing in humans. We argue that genetic treatment of sporadic Alzheimer's disease, breastand ovarian-cancer causing BRCA1/2 mutations and the introduction of HIV resistance in humans should be considered within a new category of genetic protection treatments. We find that if this category is not introduced, life-altering research might be unnecessarily limited by current or future policy. Otherwise ad hoc decisions might be made, which introduce a risk of unforeseen moral costs, and might overlook or fail to address some important opportunities.
Both the planning of EurSafe2021 and the origin of this book were profoundly influenced by the Covid-19 pandemic, and we are extremely pleased to see that so many contributions still arrived. We would like to thank all authors for sharing their work and insights and all reviewers for their muchappreciated expertise on the vast range of topics. We are grateful for the support and encouragement received from the EurSafe board and Svenja Springer, in preparing this conference despite the challenging circumstances. Our special thanks go to
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